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. 2017 Feb 27;2017(2):CD001911. doi: 10.1002/14651858.CD001911.pub3
Methods Multicentre, randomised, parallel‐group, double‐blinded study over 10 centres in the USA with separate randomisation schemes used for each seizure type.
Four treatment arms: carbamazepine, phenytoin, phenobarbitone, primidone
Dates conducted: Not stated
Participants Adults with previously untreated or under‐treated simple or complex partial or secondary generalised tonic‐clonic seizures
Number randomised: PHT = 165, CBZ = 155
100% partial epilepsy. 278 (87%) men. Mean age (range): 41 (18 to 82) years
Range of follow‐up: 0 to 66 months
Interventions Monotherapy with PHT or CBZ. Median daily dose achieved: PHT = 400 mg/day, CBZ = 800 mg/day
Outcomes Participant retention/time to drug failure (length of time participant continued to take randomised drug)
Composite scores of seizure frequency (seizure rates and total seizure control) and toxicity
Incidence of side effects
Notes IPD provided for all randomised participants. All outcomes in this review calculated from IPD
Funding: supported by the Veterans Adminstration Medical Research Service Cooperative Studies Program (CS 118)
Conflicts of interest: None stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants randomised with stratification for seizure type. Method of randomisation not stated and not provided by authors
Allocation concealment (selection bias) Unclear risk No information provided in the publication or by study authors
Blinding of participants and personnel (performance bias) All outcomes Low risk Double‐blind (participants and personnel) achieved using an additional blank tablet
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Unclear if outcome assessment was blinded, no information provided
Incomplete outcome data (attrition bias) All outcomes Low risk Attrition rates reported, all randomised participants analysed from IPD provided1
Selective reporting (reporting bias) Low risk All outcomes reported or calculated with IPD provided1
Other bias Low risk No other bias detected